Metabolic Syndrome in Childhood Cancer Survivors

Completed

• Conditions: Brain and Central Nervous System Tumors; Leukemia; Lymphoma; Metabolic Syndrome; Sarcoma
• Interventions: Other: metabolic assessment; Other: questionnaire administration

• Registration Number: NCT00920738
• Lead Sponsor: University of Minnesota

Brief Summary

RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood cancer may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying metabolic syndrome in survivors of childhood cancer and in their healthy sisters and brothers.

Detailed Description

OBJECTIVES:

Primary

* Determine the manifestations of metabolic syndrome (MS) in children and adolescents who are survivors of childhood cancer (CCS).

* Compare the prevalence of MS in CCS to that of matched healthy siblings of similar age and gender.

* Evaluate insulin resistance (as measured by the euglycemic insulin clamp) in CCS and compare to that of healthy siblings of similar age and gender.

* Assess the extent to which prevalent obesity and insulin resistance are correlated with other factors that have been identified in the causal pathway associated with the development of the MS that may be altered in the CCS ( e.g., growth-hormone secretion, adipokines \[adiponectin, leptin\], inflammatory mediators \[e.g., interleukin-6\], tumor necrosis factor-α, and C-reactive protein).

* Obtain dietary and physical activity assessments of CCS and healthy siblings.

Secondary

* Explore demographic (age at treatment, sex-specific differences) and treatment-related factors (exposures and dose-related associations with chemotherapeutic agents, radiation, steroids) as potential correlates with insulin resistance, vascular function, and MS in CCS.

OUTLINE: Patients undergo a comprehensive medical examination including current and past medical history, family history, review of prescription medications, a physical examination including a body and visceral-fat assessment, and anthropometric (DEXA and bone-age x-ray) and blood pressure measurement. Blood samples are collected to measure growth hormone, adipokines (adiponectin, leptin), cytokines (IL-6 and CRP), fasting insulin, fasting glucose, lipids, oxidized LDL, hypothalami-pituitary-gonadal function (estrogen, FSH, LH, testosterone), and thyroid function (free T4 and TSH). Patients also complete questionnaires on dietary intake and physical activity.

Healthy siblings undergo a complete medical examination as patients do, including blood samples collection and questionnaire administration.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-15
• Primary Completion: 2010-07
• Study Completion: 2011-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-21
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 512

Inclusion Criteria

• Subjects must be survivors of childhood cancer, treated at Fairview-University Medical Center or Children's Hospitals and Clinics of Minneapolis and St Paul or siblings of survivors.
• Subjects will be 9-17 years old at the time of their visit.
• Subjects who are cancer survivors must have survived childhood cancer for a minimum of 5 years and be in remission.

Exclusion Criteria

• Eligibility will not be restricted by race or sex.
• Any women currently pregnant will not be eligible, but may participate 3 or more months after the end of her pregnancy if the study is still ongoing.
• Subjects who underwent hematopoietic cell transplant (HCT) are not eligible for this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer Survivors	questionnaire administration	Subjects who are cancer survivors must have survived childhood cancer (diagnosed \< or = 18 years) for a minimum of 5 years and be in remission.
Healthy Siblings of Cancer Survivor	metabolic assessment	Healthy populations similar in age and gender distribution, derived from a frequency matched control population of 350 healthy siblings.
Cancer Survivors	metabolic assessment	Subjects who are cancer survivors must have survived childhood cancer (diagnosed \< or = 18 years) for a minimum of 5 years and be in remission.
Healthy Siblings of Cancer Survivor	questionnaire administration	Healthy populations similar in age and gender distribution, derived from a frequency matched control population of 350 healthy siblings.

Primary Outcome Measures

Name	Time	Method
Insulin resistance (IR) in CCS vs controls	Day 1 and Day 2
Dietary and a physical activity assessments of CCS vs controls	Day 1 and Day 2
Correlation of obesity and IR to other factors associated with the development of the MS that may be altered in the CCS	Day 1 and Day 2
Metabolic syndrome (MS) in survivors of childhood cancer (CCS) vs controls	Day 1 and Day 2

Secondary Outcome Measures

Name	Time	Method
Demographic and treatment-related factors as potential correlates with IR, vascular function, and MS in CCS	Day 1 and Day 2

Trial Locations

Locations (1)

University of Minnesota Children's Hospital - Fairview; 🇺🇸 Minneapolis, Minnesota, United States